Orlistat Pregnancy and Breastfeeding Warnings

Orlistat Pregnancy Warnings

Neither embryotoxicity or teratogenicity have been observed at doses 23 (rats) and 47 (rabbits) times the calculated daily human dose. Administration to rats from late gestation to weaning at 50 times the recommended human dose did not affect pup survival or development. In humans, weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Current recommendations in obese and overweight women advise a minimum weight gain and no weight loss due to the necessary weight gain in maternal tissues during pregnancy. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated

AU TGA pregnancy category: B1US FDA pregnancy category: X

Comments: -Weight reduction using appetite suppressant drugs is not recommended during pregnancy.-If pregnancy occurs while taking this drug, the mother should be apprised of the potential hazard of maternal weight loss to the fetus.

Orlistat Breastfeeding Warnings

Use with caution

Excreted into human milk: Unknown Excreted into animal milk: Data not available

Comments: -The effects in the nursing infant are unknown.

As this drug is poorly orally absorbed, it is unlikely that it is excreted into milk or absorbed by the nursing infant. However, this drug has been shown to decrease the absorption of fat-soluble vitamins and beta-carotene which would then be decreased in breastmilk. Product manufacturers recommended against taking this drug while breastfeeding.